Identity
- Trade Name
- Spectra FDA UDI
- Generic Name
- Breast pump, electric FDA UDI
- Device Name
- This is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with necessary connecting parts including Cara Cups, and instruction for use. So the user can use the device right after receiving them. FDA UDI
- Model / Reference
- Spectra 9 Plus (with CaraCups) FDA UDI
- Description
- This is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with necessary connecting parts including Cara Cups, and instruction for use. So the user can use the device right after receiving them. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809108015754 FDA UDI
- 510(k) Number
- K162415 FDA UDI
- FDA Product Code
- HGX FDA UDI
- GMDN Term
- Breast pump, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breast pump, electric
Spectra by Uzinmedicare Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162415 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Uzinmedicare Co., Ltd.
Sources (1)
- FDA UDI e38f8a69-2f41-4afe-aa7c-78e2a2d8bdae 35 fields · synced Jun 8, 2026